Abstract
The choice of suitable excipients is a base requirement in pharmaceutical manufacturing. For solid dosage forms, such excipients, as well as API, are powders that rarely show adequate properties for a direct employment in manufacturing. Therefore, powder processing is generally required. The long experience in powder processing has led to well-established techniques, such as milling, blending, drying, and filling, that however require continuous improvement to comply with the fast growing automation and in process control technologies. Moreover, standards and regulations have to evolve to keep pace with the technological progress. The future development of new manufacturing concepts will demand rethinking of traditional methods and particle engineering approaches.
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Notes
- 1.
GMPÂ =Â Good manufacturing practices are that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization or product specification. Good manufacturing practices are concerned with both production and quality control; GLPÂ =Â good laboratory practices is a quality system concerned with the organizational process and the conditions under which nonclinical health and environmental safety studies are planned, performed, monitored, recorded, archived, and reported.
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Hickey, A.J., Giovagnoli, S. (2018). Powder and Particle-Dependent Traditional Manufacturing Processes (Unit Operations). In: Pharmaceutical Powder and Particles. AAPS Introductions in the Pharmaceutical Sciences. Springer, Cham. https://doi.org/10.1007/978-3-319-91220-2_8
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DOI: https://doi.org/10.1007/978-3-319-91220-2_8
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